MAL-ED Metabolic: A Follow-Up of Chronic Disease at Puberty

NCT05121935 | Not Yet Recruiting

• 1 other identifier: 200340
• Study Type: observational
• Target: 254
• Locations: 0 countries
• Sites: N/A

Brief Summary

The concept that the roots of cardiometabolic disease start in early life was established by Dr. David Barker, who documented relationships between low birthweight (as a marker for challenges during gestation) and later cardiovascular disease (CVD). Later work has suggested that post-natal challenges (similar to prenatal ones) may also exhibit links to later cardiometabolic disease, with the strongest links appearing to be between low weight in early childhood and later hypertension and high waist circumference (WC). However, assessments for the relationship between early childhood challenges and insulin resistance and glucose regulation have been lacking and long-term cohort studies are few. In this project, we aim to assess children initially followed as part of The Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health (MAL-ED) study, where they received frequent measures of anthropometry and laboratory assessments for intestinal pathogens. These children are now of peri-pubertal age--a time period associated with metabolic shifts. We will assess for glucose dysregulation and findings associated with the metabolic syndrome, and we will analyze potential associations between current chronic disease risk findings with early life poor growth and intestinal pathogen carriage rate. As such, we hope to uncover potential targets in early life health to reduce later chronic disease risk.

Conditions

Growth Failure; Intestinal Infection; Metabolic Syndrome; Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

• Current Systolic BP--relationship to number of enteric pathogens by age 2 years

  Regression analysis of current systolic BP z-score vs. number enteric pathogens by age 2 years (from MAL-ED)

  Measured during current study (1 year +/- 3 months)

Secondary Outcomes (15)

• Current Systolic BP--relationship to BMI z-score at age 2 years

  Measured during current study (1 year +/- 3 months)

• Current Diastolic BP--relationship to number of enteric pathogens by age 2 years

  Measured during current study (1 year +/- 3 months)

• Current Diastolic BP--relationship to BMI z-score at age 2 years

  Measured during current study (1 year +/- 3 months)

• Current BMI z-score--relationship to number of enteric pathogens by age 2 years

  Measured during current study (1 year +/- 3 months)

• Current waist circumference--relationship to number of enteric pathogens by age 2 years

  Measured during current study (1 year +/- 3 months)

Study Arms (1)

MAL-ED cohort

Children initially followed from birth through 2 years old in the MAL-ED study (with some additional assessments in follow-up studies since then).

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This is a follow-up study of children who were originally in the MAL-ED cohort.

You may qualify if:

• Participated in original MAL-ED cohort

You may not qualify if:

• Did not participate in original MAL-ED cohort

Sponsors & Collaborators

• University of Virginia: lead
• Haydom Lutheran Hospital: collaborator

Related Publications (5)

• DeBoer MD, Lima AA, Oria RB, Scharf RJ, Moore SR, Luna MA, Guerrant RL. Early childhood growth failure and the developmental origins of adult disease: do enteric infections and malnutrition increase risk for the metabolic syndrome? Nutr Rev. 2012 Nov;70(11):642-53. doi: 10.1111/j.1753-4887.2012.00543.x.

  PMID: 23110643 BACKGROUND

• DeBoer MD, Chen D, Burt DR, Ramirez-Zea M, Guerrant RL, Stein AD, Martorell R, Luna MA. Early childhood diarrhea and cardiometabolic risk factors in adulthood: the Institute of Nutrition of Central America and Panama Nutritional Supplementation Longitudinal Study. Ann Epidemiol. 2013 Jun;23(6):314-20. doi: 10.1016/j.annepidem.2013.03.012. Epub 2013 Apr 19.

  PMID: 23608305 BACKGROUND

• Mduma ER, Gratz J, Patil C, Matson K, Dakay M, Liu S, Pascal J, McQuillin L, Mighay E, Hinken E, Ernst A, Amour C, Mvungi R, Bayyo E, Zakaria Y, Kivuyo S, Houpt ER, Svensen E. The etiology, risk factors, and interactions of enteric infections and malnutrition and the consequences for child health and development study (MAL-ED): description of the Tanzanian site. Clin Infect Dis. 2014 Nov 1;59 Suppl 4:S325-30. doi: 10.1093/cid/ciu439.

  PMID: 25305305 BACKGROUND

• Scharf RJ, Rogawski ET, Murray-Kolb LE, Maphula A, Svensen E, Tofail F, Rasheed M, Abreu C, Vasquez AO, Shrestha R, Pendergast L, Mduma E, Koshy B, Conaway MR, Platts-Mills JA, Guerrant RL, DeBoer MD. Early childhood growth and cognitive outcomes: Findings from the MAL-ED study. Matern Child Nutr. 2018 Jul;14(3):e12584. doi: 10.1111/mcn.12584. Epub 2018 Feb 2.

  PMID: 29392824 BACKGROUND

• Nemati K, Michael YZ, Hhando BP, Jatosh S, Houpt ER, Mduma E, DeBoer MD. Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study. BMJ Open. 2025 Aug 21;15(8):e100955. doi: 10.1136/bmjopen-2025-100955.

  PMID: 40840991 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will collect serum for later testing of markers of health, nutrition and inflammation, including C-reactive protein, IGF-1 and insulin.

MeSH Terms

Conditions

Failure to Thrive; Metabolic Syndrome; Glucose Intolerance

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Study Officials

• Mark D DeBoer, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Estomih Mduma, MPH

  Haydom Global Health Research Centre

  STUDY DIRECTOR

Central Study Contacts

Mark D DeBoer, MD

CONTACT

14349245956; deboer@virginia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Division of Pediatric Endocrinology

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion (Estimated): February 1, 2031
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share